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  • Dispositivo 98
  • Fabricante 6
  • Evento 124969
  • Implante 0
MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical devi...
  • Modelo / Serial
    Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)HLA-DRB1 SSO Typing KitSupplier Code: 628923Lot Numbers: TL628923 and TL628923sLot Numbers: 04226A and 11125AHLA-DQA1/B1 SSO Typing Kit Supplier Code: 628930Lot Numbers: TL628930, TL628930s and TL628930pLot Numbers: 3004970, 06306A and 10205AARTG Numbers: 217874 and 217873
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)
ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
Pak Lx Assay
  • Modelo / Serial
    Pak Lx AssayProduct Code: GT-PLXLot Number: 3003658with Conjugate Lot: 3003881Lot Number: 3004022with Conjugate Lot: 3003881ARTG Number: 217307
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Pak Lx Assay
FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An ...
  • Modelo / Serial
    FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)Product Code: BM-MX005-sLot Number: LE124535Expiry: 31 Jan 2018ARTG Number: 198370
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)
Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)Catalogue Number: RE52611Lot Numbers: ECO142, ECO143Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31ARTG Number: 210636 (Abacus ALS - Clinical chemistry hormone IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
  • Modelo / Serial
    Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical DeviceLot Number: 0014.Abacus ALS part number: PU14563901, Manufacturers part number: 14-5639-01ARTG Number: 229585 (Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medi...
  • Modelo / Serial
    Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical deviceMaterial Numbers: 14-4450-01 and 14-4451-01Multiple Affected Lot NumbersARTG: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical device
Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD...
  • Modelo / Serial
    Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD)With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA testsARTG Number: 229542
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD) With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests
RE51021 / MuSK-Ab ELISA
  • Modelo / Serial
    RE51021 / MuSK-Ab ELISA Lot EMU124ARTG number: 210637
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de RE51021 / MuSK-Ab ELISA
Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)Article Number: 12-3800-01All instrument software (ISW) versionsAll Lot/Serial NumbersARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)
ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)Product Number: 14-4837-01Lot Number: 999G5ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
EliA Sample Diluent
  • Modelo / Serial
    EliA Sample DiluentArt. No. 83-1023-01Lot Numbers: JM3Y, JS0B, JP87, JK5N, JU9CBottle Lots: BVXDR/JM3W, BVXDT/JS0A, BVXDS/JP83, BVXDP/JK5M, BVXDU/JU9BARTG Number: 229543
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA Sample Diluent
ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).Lot Numbers: AAS0D (exp 31 Mar 2012)AAS0E (exp 31 Mar 2013)AAS0F (exp 31 May 2014)AAS0G (exp 30 Nov 2014)AAS0H (exp 31 Jan 2015)AASG1 (exp 31 Jul 2016)AASG2 (exp 30 Jun 2016)AASG3 (exp 30 Jun 2018)ARTG Number:186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medic...
  • Modelo / Serial
    IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).Reference Number: E-KR-480Lot Numbers: 013A & 016AARTG Number: 274979
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).Kit Item Number: CR2003Lot Numbers: 161019161504NZ & 161007110553JGARTG Number: 272537
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. A...
  • Modelo / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).ImmunoCAP Specific IgG/IgG4 i1 Control HArticle Number: 10-9475-01Vial Lots: with expiry date up to July 2017 (C6XAX or older)ImmunoCAP Allergen i1, Honey bee venomArticle Number: 10-4143-01Lot Numbers: 389B7, 389B8, 389B9, 389BA & 389BB ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).
Coxiella burnetii IFA IgG Kit
  • Modelo / Serial
    Coxiella burnetii IFA IgG KitReference Number: PCOBUGKit Lot Number: 15C304Slide Lot Number: 15C403ARTG Number: 212957An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Coxiella burnetii IFA IgG Kit
MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD). Product Number:TL-SR-800-10433-24Lot Number: 18-299-11-C ARTG Number: 288368Abacus dx - Multiple human leukocyte antigens (HLA) typing IVDs
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device ...
  • Modelo / Serial
    MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)MIA FORA NGS HLA Server, Linux SR-790-00017 or Windows SR-790-00020MIA FORA NGS Software, Linux SR-850-00043, Windows SR-850-00062 or Registry SR-790-00068ARTG Number: 288607(Abacus dx Pty Ltd - Interpretive software IVDs)
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)
EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)Catalogue Number: PU14566801Lot number: 0015Expiry date: 31/01/2019ARTG: 229585Abacus dx - Clinical chemistry autoimmune IVDs
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database...
  • Modelo / Serial
    Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)Typing Kit Catalogue Numbers: TL628915 and TL628915sARTG Numbers: 257272 , 217871
  • Manufacturer
    Abacus dx Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.
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